Leading Discovery, Pipeline Research, and Computational Immunology to explore innovation in Tumor Infiltrating Lymphocyte therapies.

Member of the leadership team of Technical R&D responsible for articulating the vision for future Cell and Gene Therapies (CGT) platforms, and implementing solutions to current process bottlenecks through organizational change and technical innovation. Led a team of 25 associates with responsibilities for cell process, analytic, and vector process development. Established global working groups in deep analytics, bioinformatics, automation, and process innovation. Contributed to IND and BLA filings, SOP development, risk assessment, change control implementation, comparability studies, and global CMC regulatory filings. Coordinated deep analytics efforts for mechanistic understanding of CGT products and pipeline, including FACS, CyTOF, advanced proteomics, RNAseq, NGS, and proprietary analytics tools.

Responsible for process design and analytics development for cell and transduction-based advanced therapies, Established scalable GMP compliant production strategies, and drove global strategy for cell based breakthrough advanced therapies. Influenced partner organizations to adapt optimized platforms for continuous improvements and enabled seamless transfer of early phase processes to worldwide operations locations.

* Production of individualized cell and gene therapies for Phase I, II, III clincal trials* Process design and product characterization for first-in-man studies of CD19 CAR, ESO TCR, young TIL, EGFRvIII CAR, and many other T cell based oncology products* SME and strategic consulting in risk assesment, manufacturing methods and regulatory compliance* Operations consulting for scale-up, qualification assays, supply chain security, and workflow optimization* Translated bench discoveries to innovative patient therapies in more than 50 clinical protocols* Managed a cGMP cell and gene therapy laboratory responsible for transformative change in the immunotherapy space, supplying cell products for clinical trials headed by Dr. Steven A. Rosenberg and Surgery Branch Colleagues